MedTrace Logo

High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window Surgery

NCT07432607 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-05

No results posted yet for this study

Summary

This is a prospective, randomized, parallel-group clinical trial designed to evaluate the effects of high-flow nasal oxygen therapy (HFNOT) versus conventional oxygen mask (COM) on perioperative hypoxia in patients undergoing video-assisted thoracoscopic (VATS) pericardial window procedures under sedoanalgesia. The pericardial window procedure, indicated for diagnostic and therapeutic drainage of pericardial effusion, is traditionally performed under general anesthesia. However, the use of non-intubated VATS with sedoanalgesia has gained popularity due to reduced morbidity, shorter recovery, and avoidance of complications associated with general anesthesia, especially in elderly and comorbid patients.

During non-intubated VATS, the occurrence of hypoxia and hemodynamic instability may be exacerbated by procedural pneumothorax and underlying cardiac pathology. High-flow nasal oxygen therapy may provide physiological benefits in this setting by reducing airway resistance, improving alveolar ventilation, and minimizing dead space.

The primary outcome of the study is to compare the incidence of perioperative hypoxia between HFNOT and COM groups. Secondary outcomes include patient comfort, intraoperative oxygenation profiles, hemodynamic stability, and recovery parameters. The trial will be conducted at a single academic center with eligible patients randomized into two treatment arms.

Conditions

  • Hypoxemia During Surgery

Interventions

DEVICE

High-Flow Nasal Oxygen Therapy (HFNOT)

Heated and humidified oxygen will be administered through a high-flow nasal cannula. Flow rates will up to 70 L/min with an FiO₂ of 0.21 to 1.00, delivered at a temperature of 37°C. The intervention will be applied from entry into the operating room until the end of the surgical procedure during sedoanalgesia-guided non-intubated VATS pericardial window surgery.

DEVICE

Conventional Oxygen Mask (COM)

Oxygen will be delivered via a standard face mask up to 15 L/min with an FiO₂ of 0.21-1.00. The oxygen support will be provided from entry into the operating room until the end of the procedure during sedoanalgesia-guided non-intubated VATS pericardial window surgery.

Sponsors & Collaborators

  • Ebru Girgin Dinc

    lead OTHER

Principal Investigators

  • Atakan ERKILINC, MD, Ass. Prof. · Kosuyolu Kartal Heart Training and Research Hospital

  • Esin ERDEM, MD · Kosuyolu Kartal Heart Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-12-30
Completion
2027-02-28

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07432607 on ClinicalTrials.gov